AzTrials
AzTrials

Hematologic MalignancyICOSENIORHEMNCT04057443

Nutritional and Physical Exercise Intervention in Older Patients With Malignant Hemopathies

A study testing Nutritional support, Physical exercise and Hematologic Drug in people with Hematologic Malignancy and Old Age; Debility, run by Maite Antonio, MD, Phd at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Clinical trial to analyze the impact of nutrition and physical exercise intervention program on the completion of treatment in older patients 70 years or older with malignant hemopathology Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Hematologic Malignancy, Old Age; Debility
What is being tested?
Nutritional support, Physical exercise and Hematologic Drug
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSpain
Study dates
11 Apr 2019to 1 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • hematological pathology (myelodysplastic syndromes, lymphoproliferative syndromes, multiple myeloma)
  • considered able to practice physical exercise
  • signed informed consent

Who cannot join

  • other hematological pathology
  • considered unable to practice physical exercise

Trial locations and contacts

1 site in 1 country.

Maite Antonio, MD, PhD contact

+34692083987

marebollo@iconcologia.net

Josep Maria Borras, MD,PhD,Prof contact

+34932607417

jmborras@iconcologia.net

Spain1 site, 1 recruiting

  • Institut Català d'Oncologia

    L'Hospitalet de Llobregat, Barcelona, 08908

    Maite Antonio, MD,PhD, +34692083987, marebollo@iconcologia.net

    Recruiting

Other trials in Spain

About this study

Official title: Impact of a Nutritional and Physical Exercise Intervention Program on Oncological Treatment Completion in Patients ≥70 Years Old With Malignant Hemopathies:ICOSENIORHEM Randomized Clinical Trial

Clinical trial to analyze the impact of nutrition and physical exercise intervention program on the completion of treatment in older patients 70 years or older with malignant hemopathology

Read the detailed description

OBJECTIVE:

This study aims to determine wether a geriatric intervention based on an individualized program of physical exercise and nutritional support improves the ability to complete oncological treatment at the doses and time initially planned in patients ≥ 70 years affected by hematological malignancies.

DESIGN:

Prospective, clinical trial, randomized, parallel and open groups.

SETTING:

Patients ≥ 70 years recently diagnosed of malignant hematological pathology in a comprehensive cancer center

INTERVENTION:

All those patients who meet the inclusion criteria and agree to participate, will sign the corresponding informed consent and will be assessed through a CGA (comprehensive geriatric assessment), that includes the performance of a physical condition test (SPPB), and randomized to the study group or control group. Patients in the study group will participate in an intervention program with nutritional support and physical exercise during the period in which they are receiving oncological treatment or for a maximum period of 6 months. The patients of the control group will pass to follow up. All patients, regardless of the branch of study to which they are assigned, will receive the oncological treatment indicated by their doctor and a standard follow-up according to the current care protocols in the center.

DETERMINATIONS:

Main variable: proportion of adherence to treatment calculated as the percentage between the dose administered and the prescribed. Adherence over 80% will be considered acceptable.

Secondary variables: geriatric, nutritional and physical-condition parameters before and after the intervention, quality of life before and after the intervention, toxicity and complications during treatment and response to treatment.

Being tested
Nutritional support, Physical exercise, Hematologic Drug
Keywords
older, physical exercise, nutrition support, hematologic malignancies, geriatric assessment, geriatric intervention
Medical subject headings
Hematologic Neoplasms, Frailty, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional supportOther

    Nutritional support will be given to all patients according with their nutritional body composition parameters (Nutritional assessment and sarcopenia evaluation). It could be diet counselling, oral supplemented nutrition, enteral nutrition o parenteral nutrition.

  • Physical exerciseOther

    The exercise program, designed, applied and monitored by research staff of the Physiology Unit, will have duration of 24 weeks (6 months). The program will have a mixed structure, the participants in an individual way fulfill their training and attend group sessions (8 subjects). In addition, 3 days a week should conduct sessions that will focus on the work of balance and general strength.

  • Hematologic DrugDrug

    The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.

Study groups in NCT04057443
Study groupRoleWhat they receive
Intervention groupExperimentalPatients in the intervention group will follow the standard treatment and follow-uo according to the clinical protocol of the institution and will participate in an intervention program with physical exercise and nutritional support during the period in which they are receiving oncological treatment or for a maximum period of 6 months.
Receives: Other: Nutritional support; Other: Physical exercise; Drug: Hematologic Drug
Control groupActive comparatorThe patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
Receives: Drug: Hematologic Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to oncological treatment

    Percentage between the dose administered and the prescribed.

    Measured: Change from baseline and after finishing treatment or 6 months

Secondary outcomes (17)

  1. Risk of vulnerability

    Vulnerable Elders Survey (VES-13) (numeric variable)

    Measured: Baseline versus 6 months (end of intervention) versus 12 months

  2. Geriatric assessment

    Geriatric Assessment in Hematology (GAH scale) (numeric variable)

    Measured: Baseline versus 6 months (end of intervention) versus 12 months

  3. Nutritional screening

    Mini-Nutritional Assessment (MNA) (numeric variable)

    Measured: Baseline versus 6 months (end of intervention) versus 12 months

  4. Functional capacity

    Basic activities of daily life (ABVD) - (Barthel scale) and instrumental activities of daily life (IADL) (Lawton-Body scale), fatigue (Borg scale) (numeric variable)

    Measured: Baseline versus 6 months (end of intervention) versus 12 months

  5. Physical condition screening

    Short Portable Physical Performance (SPPB) test. Numeric variable.

    Measured: Change from baseline versus 6 months (end of intervention) versus 12 months

  6. Physical condition tests

    Walking test 4 metres, Up-and-go test (seconds)

    Measured: Baseline versus 6 months (end of intervention) versus 12 months

  7. Body mass index

    Weight and height will be combined to report body mass index (BMI) in kg/m2

    Measured: Baseline versus 6 months (end of intervention) versus 12 months

  8. Anthropometric evaluation

    Anthropometric evaluation of waist, hip, arm, thigh and leg perimeters (cm).

    Measured: Baseline versus 6 months (end of intervention) versus 12 months

  9. Body composition

    Body mass measured with electrical bioimpedance

    Measured: Baseline versus 6 months (end of intervention) versus 12 months

  10. Performance of muscular strength

    Strength measured by Isometric dynamometry of hands (hand grip) and legs (flex-extension) (KgF)

    Measured: Baseline versus 6 months (end of intervention) versus 12 months

  11. Functional capacity assessment

    6-minute walk test to assess functional capacity.

    Measured: Change from baseline versus 6 months (end of intervention) versus 12 months

  12. Assessment of lower limbs strengh

    Test to sit and get up in 30 seconds

    Measured: Change from baseline versus 6 months (end of intervention) versus 12 months

  13. Average number of exercise sessions completed

    Number of exercise sessions completed by each participant in the intervention group.

    Measured: Through study completion, an average of 6 months

  14. Incidence of adverse effects

    Frequency and severity of adverse effects according to CTCAE v4.

    Measured: Through study completion, an average of 6 months

  15. Quality of life Assessment

    Quality of Life Assessment: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)for old patients with cancer. (EORTC QLQ-ELD14): numeric variable.

    Measured: Change from baseline versus 6 months (end of intervention) versus 12 months

  16. Disease progression

    Time to treatment failure, time to disease progression or death from any cause, and time to disease progression

    Measured: Change from baseline and after 2 years

  17. Survival

    Disease-free survival, overall survival, and cancer-specific survival.

    Measured: Change from baseline and after 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2019
  2. Study start11 Apr 2019
  3. Primary completion1 Jun 2021 (estimated)
  4. Study completion1 Jun 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel design
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04057443
Sponsor's protocol ID
ICOSENIORHEM
Other IDs
PR157/18
Acronym
ICOSENIORHEM
Status last verified
Aug 2019
First submitted
11 Jun 2019
Last updated
30 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ernst M, Wagner C, Oeser A, Messer S, Wender A, Cryns N, Brockelmann PJ, Holtkamp U, Baumann FT, Wiskemann J, Monsef I, Scherer RW, Mishra SI, Skoetz N. Resistance training for fatigue in people with cancer. Cochrane Database Syst Rev. 2024 Nov 28;11(11):CD015518. doi: 10.1002/14651858.CD015518.

    PubMed 39606939

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional support, Physical exercise and Hematologic Drug in people with Hematologic Malignancy and Old Age; Debility, run by Maite Antonio, MD, Phd at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maite Antonio, MD, PhD (+34692083987, marebollo@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adherence to oncological treatment (time frame: Change from baseline and after finishing treatment or 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04057443, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in